Cerezyme

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Imiglucerase 400 U (per 10 ml -biological product from recombinant CHO cells);  

Tilgjengelig fra:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Imiglucerase 400 U (per 10 ml -biological product from recombinant CHO cells)

Dosering :

40 U/mL

Legemiddelform:

Powder for infusion

Sammensetning:

Active: Imiglucerase 400 U (per 10 ml -biological product from recombinant CHO cells)   Excipient: Citric acid monohydrate Mannitol Nitrogen Polysorbate 80 Sodium citrate dihydrate

Enheter i pakken:

Vial, glass, 10mL vial, 400 U

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Lonza Biologics Inc

Indikasjoner:

Cerezyme is indicated for long - term enzyme replacement therapy for patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions: a) anaemia; b) thrombocytopenia; c) bone disease; d) hepatomegaly or splenomegaly.

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, glass, 10mL vial - 400 U - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisasjon dato:

2010-08-16

Informasjon til brukeren

Page 1 of 3
CEREZYME

_ _
_[SERAH-ZIME]_
_Imiglucerase-rch [im-e-glue-sar-aze R.C.H] 400 U, Powder for
Injection _
CONSUMER MEDICINE INFORMATION_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cerezyme.
It does not contain all the available
information.
It does not take the place of talking to
your treating physician or a trained
health care professional.
All medicines have risks and benefits.
Your treating physician has weighed
the risks of you or your child having
Cerezyme against the benefits they
expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR TREATING
PHYSICIAN OR NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CEREZYME IS
USED FOR
Cerezyme is used as enzyme
replacement therapy to treat patients
who have a confirmed diagnosis of
Type I or Type 3 Gaucher disease,
who
show signs of the disease such as:
anaemia (low number of red blood
cells), low numbers of platelets (a type
of blood cell) which can lead to a
tendency to bleed, spleen or liver
enlargement or bone disease. Gaucher
disease is a disease in which the
enzyme β-glucocerebrosidase in the
body does not work properly.
_ _
_ _
_HOW IT WORKS _
Patients with Gaucher disease do not
produce enough of their own active
enzyme, β-glucocerebrosidase. The
reduced β-glucocerebrosidase activity
in patients results in the accumulation
of a fatty substance in the body called
glucocerebroside. Cerezyme is an
enzyme replacement therapy that is
intended to restore a level of enzyme
activity enough to remove the built up
glucocerebroside and to prevent further
build up.
BEFORE YOU ARE GIVEN
CEREZYME
_WHEN YOU OR YOUR CHILD MUST _
_NOT BE GIVEN IT _
DO NOT TAKE CEREZYME IF YOU OR YOUR
CHILD HAVE A KNOWN, SEVERE, LIFE-
THREATENING ALLERGIC REACTION TO:
•
Cerezyme
•
any of the ingredients listed at the
end of this leaflet
Symptoms of an allergic reaction may
include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue or
other parts of the body
•
s

Preparatomtale

New Zealand Data Sheet
Cerezyme - Imiglucerase
1
cere-ccdsv5-dsv4-12jun23
NEW ZEALAND DATA SHEET
1. CEREZYME POWDER FOR INFUSION
CEREZYME® Powder for infusion, 40U/mL, 400U/vial
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 400 units* of imiglucerase**.
After reconstitution, the solution contains 40 units (approximately
1.0 mg) of imiglucerase
per mL (400U/10 mL).
*An Enzyme Unit (U) is defined as the amount of enzyme that catalyses
the hydrolysis of one
micromole of the synthetic substrate para-nitrophenyl

-D-glucopyranoside (pNP-Glc) per
minute at 37

C.
**Imiglucerase is a modified form of human acid

-glucosidase and is produced by
recombinant DNA technology using a mammalian Chinese Hamster Ovary
(CHO) cell
culture, with mannose modification for targeting macrophages.
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Cerezyme is a white to off-white powder.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cerezyme (imiglucerase) is indicated for long-term enzyme replacement
therapy for patients
with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic
neuronopathic (Type 3)
Gaucher disease who exhibit clinically significant non-neurological
manifestations of the
disease.
The non-neurological manifestations of Gaucher disease include one or
more of the following
conditions:
a)
anaemia;
b)
thrombocytopenia;
c)
bone disease;
d)
hepatomegaly or splenomegaly.
New Zealand Data Sheet
Cerezyme - Imiglucerase
2
cere-ccdsv5-dsv4-12jun23
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Dosage should be individualised for each patient. Initial dosages
range from 2.5U/kg of body
weight 3 times a week to 60U/kg once every two weeks. 60U/kg every 2
weeks is the dosage
for which most data are available. Disease severity may dictate that
treatment be initiated at
a relatively high dose or relatively frequent administration. Dosage
adjustments should be
made on an individual basis, and may increase or decrea